study to determine the safety and tolerability of tg-c in subjects with back pain due to degenerative disc disease

Conditions: Degenerative Disc Disease

Summary: the goal of this study is to evaluate the safety and tolerability of tg-c in subjects with chronic discogenic lumbar back pain due to degenerative disc disease. participants will be administered a single intradiscal injection or subcutaneous injection for sham and followed up with in-clinic visits and telephone calls for 24 months.

a phase i, double-blind, randomized, sham-controlled, dose-response, study evaluating the safety and tolerability of tg-c in subjects with chronic discogenic lumbar back pain due to degenerative disc disease at 6 and 12 months, male or female subjects with chronic discogenic lumbar back pain due to degenerative disc disease at one level. tg-c is to be administered by a single intradiscal injection to the damaged disc via fluoroscopic guidance. sham will be a normal saline subcutaneous injection. subjects will be followed for 24 months with in-clinic visits and telephone calls after study drug administration.

Eligibility criteria:
inclusion criteria: * between the ages of \>= 22 and \<= 70 * provides written informed consent before undergoing any study specific procedures * chronic lower back pain for at least 6 months. back pain twice as great as leg pain measured using nrs * vas between \>= 40 and \<= 90 * odi index \>30 and \<= 80 * inadequate response to at least one medication (e.g., nsaid, acetaminophen, muscle relaxant) and some form of formal physical therapy over a period of at least 6 months, within 6-9 months of screening. * diagnosis of ddd from l1 to s1, confirmed by patient history and radiographic studies * modified pfirrmann score of 3-7 on mri * with or without contained disc herniations of \<3 mm protrusion * if more than 1 degenerative disc is identified. pd must be performed 30 days prior and ensure only one level is the pain generator * bmi \>15 and \< 30 kg/m2 * use birth control exclusion criteria: * co-morbid medical condition of the spine or upper extremities * grade 2 or higher spondylolisthesis and type iii modic changes around target disc * suspicion of full thickness annular tear at disc * history of endocrine or metabolic disorder * rheumatoid or psoriatic arthritis * compressive pathology due to stenosis or herniated or sequestered discs * symptomatic involvement of more than one lumber disc * intact disc bulge/protrusion at \>3 mm * lumbar intervertebral foraminal stenosis * previous surgery at the target disc level * epidural or facet joint steroid, platelet rich plasma (prp) or bone marrow concentrate (bmc) injections, or radio frequency ablation (rfa), within 6 months prior to baseline. * pregnant * presence of ferromagnetic implants * involved in current or pending spinal litigations * care is provided under a worker's compensation claim * physical or mental conditions * 3 or more of the 5 waddell signs * positive screen for hiv * immediate family member of other participating patients * participated within 3 months or is concurrently enrolled in non-interventional research * transient or has a history of any substance use disorder * currently incarcerated * investigator site personnel or immediate family or sponsor employee * on chronic anti-coagulation therapy or have confirmed coagulopathy * tested positive on rcr testing at screening

Keywords: degenerative disc disease